Quality Compliance and Recall Manager
: Job Details :

The Manager, Regulatory Compliance, assembles a team for site wise and/or cross departmental discussions, oversees investigation, and completes Field Alert forms pertaining to issues and events that warrant notification to The Food and Drug Administration. The Manager, Regulatory Compliance is responsible for leading activities for the processing and management of product recalls, oversight and staffing of temporary workforce, response tracking and effectiveness check monitoring, follow up, closure and reporting writing respective to a product recall or market withdrawal. The Manager, Regulatory Compliance supports with establishing new, revising and maintaining Global Quality Standards current. The Manager, Regulatory Compliance has direct interface with Site Quality Heads and Functional Heads with respect to FAR and Recalls. Essential Functions: Will be the contact person for the FDA and other regulatory agencies in regard to Field Alerts responses and will work closely with the FDA ...Manager, Compliance, Quality, Processing, Monitoring, Support, Technology